Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing

Bausch Health

Status and phase: Completed; Phase 4

Conditions: Colon Cleansing

Treatments: Drug: Polyethylene glycol; Drug: Oral sodium phosphate solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01427296

OSBP4011

Details and patient eligibility

About

The purpose of this study is to compare the safety and efficacy of OsmoPrep tablets versus HalfLytely and Bisacodyl Tablet Bowel Prep Kit in subjects who are undergoing colonoscopy.

Enrollment: 2,154 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Between 18 and 70 years of age, inclusive
• Scheduled for colonoscopy within 21 days of the screening visit
• Able to swallow tablets the size of a multivitamin without difficulty

Exclusion criteria

• History of biopsy-proven acute phosphate nephropathy
• Known allergy or hypersensitivity to treatment arms
• History of gastric stapling or bypass procedure or history of gastric retention
• History of any other sodium phosphate preparation within 6 months prior to colonoscopy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2,154 participants in 2 patient groups

OsmoPrep Tablets

Active Comparator group

Treatment:

Drug: Oral sodium phosphate solution

HalfLytely and Bisacodyl Tablet

Active Comparator group

Treatment:

Drug: Polyethylene glycol